Artificial sphincter system

ABSTRACT

The present invention relates to a kind of artificial sphincter system, which takes shape memory alloy (SMA) as its motion device, and then cooperates with controlled circuit to imitate the motion of human sphincter, especially in imitating iris. The present invention can be used in a human body, a robot or a machine.

FIELD OF THE INVENTION

The present invention relates to an artificial sphincter system, which can imitate the motion of human sphincter. In the preferred embodiment, the artificial sphincter system of the present invention is applied to imitate human iris, and it also can be used in a human body, a robot or a machine.

BACKGROUND OF THE INVENTION

The implant is designed to replace missing or defective iris in the human eye either because the patient was born without an iris (a condition called aniridia) or suffered an injury or surgical damage to the iris.

The iris is the dark part of the eye that determines eye color and surrounds the pupil, and the hole in the center of the iris controls the amount of light entering the eye. Absence of the iris would cause poor vision and very severe sensitivity to light. Implantation of this device benefits patients by allowing better light modulation into the eye and thereby improving vision and comfort.

The implants are part of first US FDA clinical trial of its kind and manufactured by Ophtec USA, a Dutch company in Groningen Holland with offices in the US. Kenneth J. Rosenthal, MD, FACS, an attending ophthalmologist who practices in Great Neck, N.Y., is primary investigator for the study.

Artificial irises have been used in Europe, Canada, the Middle East and Asia, but rarely by a small handful of surgeons in the United States because the disease, aniridia, is uncommon, affecting only about 1 out of every 50,000 people. A similar device, called the Rasch-Rosenthal Iris Diaphragm Ring, was co-invented by Dr. Rosenthal and Dr. Volker Rasch of Potsdam Germany in 1996, and Dr. Rosenthal was the world's first surgeon to implant one of these devices, with Dr. Rasch's assistance in July 1996.

However, occupying large space is one if the disadvantage of artificial iris, which would lead to other diseases after the implantation; the fragile acrylic material may be broken in the eye and then cause damage after crash, the last but not the least, the main function of most of the current artificial iris is pleasing to the eye instead of physical function. Most of the current artificial iris can not control the amount of light entering the eyes.

SUMMARY OF THE INVENTION

The present invention provides a kind of artificial sphincter system comprising:

-   -   (1) a hollow object, which has the ability of contraction and         expansion; and     -   (2) a shape memory alloy, which is connected with the hollow         object, changes its shape to imitate the motion of human muscle         by passed different amount of electric current.

DETAILED DESCRIPTION OF THE INVENTION

The three main types of shape memory alloys (50) are the copper-zinc-aluminum-nickel, copper-aluminum-nickel, and nickel-titanium (NiTi) alloys. NiTi alloys are generally more expensive and to change from austenite to martensite upon cooling; M_(f) is the temperature at which the transition is finished. Accordingly, A_(s) and A_(f) are the temperatures at which the reverse transformation from that repeated use of the shape memory effect may lead to a shift of the characteristic transformation temperatures (this effect is known as functional fatigue, as it is closely related with a change of microstructural and functional properties of the material).

The transition from the martensite phase to the austenite phase is only dependent on temperature and stress, not time, as most phase changes are, as there is no diffusion involved. Similarly, the austenite structure gets its name from steel alloys of a similar structure. It is the reversible diffusionless transition between these two phases that allow the special properties to arise. While martensite can be formed from austenite by rapidly cooling carbon-steel, this process is not reversible, so steel does not have shape memory properties.

The shape memory alloy (50) will change its shape or contract while meeting heat or an electric current which can generate heat on the shape memory alloy, the changed shape will recover to the original shape after blocking the electric current or the heat. This characteristics is applied to the artificial sphincter system of the present invention, moreover, it can imitate iris when working with a diaphragm.

The present invention provides a kind of artificial sphincter system comprising:

-   -   (1) a hollow object (60), which has the ability of contraction         and expansion; and     -   (2) a shape memory alloy (50), which is connected with the         hollow object, changes its shape to imitate the motion of human         muscle by passed different amount of electric current.

The present invention provides a kind of artificial sphincter system, which further comprises an electric power (10). In the preferred embodiment, the electric power is a solar power, which provides different amount of electric current to the shape memory alloy and let it contract or expand to control the motion of the hollow object (60) to imitate the motion of human muscle. In the general embodiment, the electric pressure of the electric power is 0˜10 voltage; in the preferred embodiment, the electric pressure of the electric power is 0˜7.5 voltage; in the best embodiment, the electric pressure of the electric power is 0˜5 voltage. In the general embodiment, the A/D value of the electric power is 0˜300 voltage; in the preferred embodiment, the A/D value of the electric power is 0˜275 voltage; in the best embodiment, the A/D value of the electric power is 0˜255 voltage.

The present invention provides a kind of artificial sphincter system, wherein the hollow object (60) is a diaphragm, which is controlled by the shape memory alloy and imitates the motion of human muscle by contraction and expansion. In the preferred embodiment, the artificial sphincter system is used to imitate an iris. In the artificial sphincter system of the present invention, a photo resistance (20) is added between the electric power and the shape memory alloy, which is used to control the amount of electric current entering the shape memory alloy by censoring the brightness of surrounding light.

In the embodiment of imitating iris, the minimal force for moving the diaphragm is 12 g, and the force for opening the diaphragm to the maximum is 20 g. Installed the photo resistance, the brightness of surrounding light when the diaphragm achieving the minimal closing is 255˜300 μW. In the embodiment of improving the similarity between the present invention and the human muscle, the shape memory alloy is divided into 4˜12 parts; in the preferred embodiment, the shape memory alloy is divided into 6˜10 parts; in the best embodiment, the shape memory alloy is divided into 8 parts.

The main function of most of the current artificial iris is pleasing to the eye instead of physical function. Most of the current artificial iris can not control the amount of light entering the eyes and can not contract or expand, the artificial sphincter system have the contraction and expansion function and can be used in a human body, a robot or a machine.

While the invention has been described and exemplified in sufficient detail for those skilled in this art to make and use it, various alternatives, modifications, and improvements should be apparent without departing from the spirit and scope of the invention.

One skilled in the art readily appreciates that the present invention is well adapted to carry out the objects and obtain the ends and advantages mentioned, as well as those inherent therein. The processes and methods for producing them are representative of preferred embodiments, are exemplary, and are not intended as limitations on the scope of the invention. Modifications therein and other uses will occur to those skilled in the art. These modifications are encompassed within the spirit of the invention and are defined by the scope of the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The number of element is as follows:

10: electric power

20: photo resistance

30: circuit board

40: connecting cable

50: shape memory alloy

60: hollow object

FIG. 1 shows (A) the virtual image and (B) the real image of the embodiment of the artificial iris.

FIG. 2 shows the opening and closing condition of the artificial iris of the present invention with (A) high brightness; (B) low brightness (the paper covered half of the photo resistance); and (C) lower brightness (the paper covered most of the photo resistance).

FIG. 3 shows the contraction and expansion control of the shape memory alloy of the artificial iris of the present invention.

FIG. 4 shows the diagram of the relationship between the pulling force and the opening and closing condition (percentage) of the artificial iris of the present invention.

FIG. 5 shows the diagram of the relationship between the 540 nm optical power and the opening and closing condition of the artificial iris of the present invention (test for 26 times).

EXAMPLES

The example of the present invention was for imitating a human iris, so the hollow object in the example was replaced by a diaphragm.

1. Manufacture of the Artificial Iris System

As shown in FIG. 1, combining the shape memory alloy and the diaphragm, making the partially electrified circuit of the shape memory alloy, censoring the brightness of the surrounding light by the photo resistance (20) on the circuit board (30), connecting with 10 voltage DC power, and connecting the circuit board and the shape memory alloy by the connecting cable (40), the artificial iris system was completed.

2. The Mechanism of the Artificial Iris System

The artificial iris system controlled the opening of the diaphragm through censoring the brightness of the surrounding light by the photo resistance (20), and then controlled the amount of electric current passing the shape memory alloy (50), the shape memory alloy would cause the opening or closing of the diaphragm by contraction and expansion. In the high brightness surrounding, there was no electric current passing the shape memory alloy, the diaphragm would maintain in the minimal opening condition avoiding the strong light entering into the eyes; In the low brightness surrounding, there was few electric current passing the shape memory alloy, the diaphragm would be slightly opened; In the lower brightness surrounding, there was more electric current passing the shape memory alloy, the diaphragm would be opened to the maximum (as shown in FIG. 2). The device regulated the amount of the light entering eyes as human iris.

3. The Condition of Contraction and Expansion of Each Part of the Shape Memory Alloy

The shape memory alloy controlled the contraction and expansion of the artificial iris in the present invention was divided into 8 parts. The control of the contraction and expansion depended on the different voltage which would be changed by the photo resistance (20) in different amount of surrounding light. The voltage was controlled in 0˜5 voltage, which influenced on the A/D value (analog to digital value), the A/D value was between 0˜225, different A/D values would cause different conditions of the contraction and expansion of each part of the shape memory alloy. As shown in FIG. 3, the voltage and the A/D value were changed when the light was becoming fade. The more number of the contracted shape memory alloy, the more area of the opened diaphragm.

4. Test of the Relationship Between the Opening of the Artificial Iris System and the Pulling Force

For measuring the force of opening and closing of the artificial iris by a load cell, the examination step was as follows:

First, fixing the diaphragm, and matching the pulling direction of the diaphragm pole and the direction of motivating direction of the load cell. Second, pulling the pole to make the diaphragm open to the certain degree by the load cell, and testing the force for 100 times. Finally, drawing a diagram of the force measured by the load cell and the opening degree (percentage) of the diaphragm, the result was shown in FIG. 5. It needed 12 g to motivate the diaphragm, and the measured force was gradually increased when the diaphragm was opening. As shown in FIG. 4,the force of the maximal opening condition of the current diaphragm was 20 g.

5. Test of the Relationship Between the Opening of the Artificial Iris System and Brightness of Surrounding Light

For measuring the relationship between the opening of the artificial iris system and brightness of surrounding light by a 540 nm light source of the photo resistance, the examination step was as follows:

First, putting the photo resistance of the artificial iris under a 540nm light source, and warping the other part by a mask to prevent the interference of outside light. Second, using different intensity to trigger different opening degree of the diaphragm and recording it. Finally, measuring the optical power by a photometer in the same intensity for 26 times, and drawing a diagram of the optical power of 540 nm and the opening degree of the diaphragm, the result was shown as FIG. 6. The artificial iris was gradually closing when the optical power was increasing, and reached the minimal closing condition when the optical power was 255˜300 μW, the result was shown as FIG. 5. 

1. An artificial sphincter system comprising: (1) a hollow object, which has the ability of contraction and expansion; and (2) a shape memory alloy, which is connected with the hollow object, changes its shape to imitate the motion of human muscle by passed different amount of electric current.
 2. The artificial sphincter system of claim 1, which further comprises an electric power to provide different amount of electric current to the shape memory alloy and let it contract or expand to control the motion of the hollow object to imitate the motion of human muscle.
 3. The artificial sphincter system of claim 1, wherein the hollow object is a diaphragm.
 4. The artificial sphincter system of claim 1, wherein a photo resistance is added between the electric power and the shape memory alloy, which is used to control the amount of electric current entering the shape memory alloy by censoring the brightness of surrounding light.
 5. The artificial sphincter system of claim 3, wherein the diaphragm is used to imitate the motion of an iris.
 6. The artificial sphincter system of claim 3, wherein the diaphragm is controlled by the shape memory alloy.
 7. The artificial sphincter system of claim 3, wherein the minimal force for moving the diaphragm is 12 g, and the force for opening the diaphragm to the maximum is 20 g.
 8. The artificial sphincter system of claim 1, wherein the shape memory alloy is divided into 4˜12 parts to improve the similarity of human muscle.
 9. The artificial sphincter system of claim 1, wherein the shape memory alloy is divided into 6˜10 parts to improve the similarity of human muscle.
 10. The artificial sphincter system of claim 1, wherein the shape memory alloy is divided into 8 parts to improve the similarity of human muscle.
 11. The artificial sphincter system of claim 2, wherein the electric pressure of the electric power is 0˜10 voltage.
 12. The artificial sphincter system of claim 2, wherein the electric pressure of the electric power is 0˜7.5 voltage.
 13. The artificial sphincter system of claim 2, wherein the electric pressure of the electric power is 0˜5 voltage.
 14. The artificial sphincter system of claim 2, wherein the A/D value of the electric power is 0˜300 voltage.
 15. The artificial sphincter system of claim 2, wherein the A/D value of the electric power is 0˜275 voltage.
 16. The artificial sphincter system of claim 2, wherein the A/D value of the electric power is 0˜255 voltage.
 17. The artificial sphincter system of claim 3, wherein the brightness of surrounding light when the diaphragm achieving the minimal closing is 255˜300 μW.
 18. The artificial sphincter system of claim 2, wherein the electric power is a solar power.
 19. The artificial sphincter system of claim 2,which is used in a human body, a robot or a machine. 